The principal objective of the Biostatistics Core Facility is to provide statistical collaborative support of the highest quality to members of the Moffitt Cancer Center & Research Institute. Collaborative services include: assistance with design of studies, analytical aspects of grant applications, protocol development, sample size determination, and quantitative analysis and interpretation of data, usually resulting in peer-reviewed research articles. Core faculty are also involved in statistical methods development motivated by these research collaborations. The Facility, led by Dr. Michael Schell, has essentially tripled in size since the last review and now includes seven full-time faculty, five staff statisticians, and three part-time core members. The large growth in the size of Biostatistics since the last review translates to a corresponding breadth and depth of expertise. Substantial gains have occurred in the analysis of gene and tissue microarrays, proteomics, SNPs, group randomized trials, biomarkers, imaging studies, and structural equations modeling. Additional areas of strength include: clinical trials, gene microarray expression, SNP analysis, biomarker analysis, HPV incidence assessment and prevention, smoking cessation, and psychosocial issues in cancer. Recent methodological advances include development of the reduced piecewise exponential model for modeling survival, and a coordinated processing plan for the analysis of candidate biomarkers. Since the Moffitt Cancer Center is one of the leading centers for patient accruals among NCI-designated cancer centers, the Core is involved in a considerable volume of protocol activity. Faculty statisticians are members of two Scientific Review Committees, both of which meet monthly, and the Protocol Monitoring Committee. The Core requests CCSG Support of $428,029, which is 25% of its operational budget. The core continues to cost-effectively support all of the research programs.